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FDA 510(k)

INTHERM TEMPORARY OCCLUSION CATHETER

K-Number: K901287 · 1991-02-20

ApplicantInterventional Therapeutics Corp.
Decision Date1991-02-20
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTHERM TEMPORARY OCCLUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1991-02-20 under 510(k) number K901287. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTHERM TEMPORARY OCCLUSION CATHETER?

INTHERM TEMPORARY OCCLUSION CATHETER is a medical device that received FDA 510(k) clearance on 1991-02-20. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K901287.

When did INTHERM TEMPORARY OCCLUSION CATHETER receive FDA 510(k) clearance?

INTHERM TEMPORARY OCCLUSION CATHETER received FDA 510(k) clearance on 1991-02-20, under 510(k) number K901287.

Who is the listed applicant for INTHERM TEMPORARY OCCLUSION CATHETER?

The FDA 510(k) record lists Interventional Therapeutics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTHERM TEMPORARY OCCLUSION CATHETER?

The FDA product code for INTHERM TEMPORARY OCCLUSION CATHETER is DYG.

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Other records listing Interventional Therapeutics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960832OCCLUSION BALLOON CATHETERK950398CATHETER, BALLOON TYPEK945588DISPOSABLE 1CC SYRINGE WITH LUER LOCKK944354CONTOUR EMBOLIK930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATORK914866ITC CONTOUR EMBOLI, MODIFICATION

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Related Devices (Code: DYG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-Ganz CathetersEdwards Lifesciences, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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